Case School of Medicine Chosen as a National Site for Study of Ethics, Legal and Social Issues in Human Genetics Research

One of Four Centers of Excellence‚ Designated by National Human Genome Research Institute

The National Human Genome Research Institute (NHGRI), part of the National Institutes of Health (NIH), announced today that the Case Western Reserve University School of Medicine will receive funding as one of four national centers of excellence in a new initiative to address some of the most pressing ethical, legal and social questions raised by recent advances in genetic and genomic research. The school’s Department of Bioethics will receive a $5.3 million grant over five years to establish the Center for Genetic Research Ethics and Law (CGREL). The new center will be directed by Eric T. Juengst, Ph.D., associate professor of bioethics at Case. Case’s application was ranked first by peer reviewers in the national competition for this new federal initiative called the Centers for Excellence in Ethical, Legal and Social Implications.

The Case center will study ethical and legal issues in the design and conduct of human genetic research, including issues regarding the protection of human research participants. CGREL researchers will study how such issues arise and are resolved in a variety of local genetic research projects, ranging from traditional family studies of disease inheritance to community-based genetic surveys, genetic testing studies, gene therapy research, and genetic studies of normal human variation. In collaboration with the other centers of excellence, the center’s goal is to develop better information for scientists, potential research participants, and policy-makers to use in decision-making about human genetic research.

“As more biomedical researchers turn to human genetics for clues about the diseases they study, the frequency with which families, scientists and research institutions encounter ethical issues in genetic research is increasing,” said Juengst. “What is a fair way to recruit families or communities to participate in genetic studies, if we want to insure that everyone is a volunteer and individual privacy is protected? When should early results about possible genetic risks be disclosed, and to whom? There are many home-grown approaches to these questions around the country, but little systematic knowledge about how well they work. Our center is designed to help address that need, on behalf of both research participants and researchers,” he said.

The new center of excellence at Case will involve researchers from six other units on campus (the University Hospitals of Cleveland Center for Human Genetics; the Center for Computational Genomics, a joint center between the medical and engineering schools; the Law/Medicine Center, a joint center between the law and medical schools; the Center for Pediatric Ethics at Rainbow Babies and Children’s Hospital; the Case Comprehensive Cancer Center/University Hospitals of Cleveland’s Ireland Cancer Center, and the University Memory and Aging Center, a medical school-UHC center) and three other institutions (Georgetown University, Howard University, and the Cleveland Clinic) in a series of collaborative research projects with Department of Bioethics faculty and staff. The new center also will work with the Weatherhead School‚s Bioscience Initiative. In addition, CGREL will host two post-doctoral fellowships, a visiting scholars program, and seed grants to other Case faculty interested in developing research on these issues.

“Thanks to the network of first class researchers in human genetics, bioethics, law and the social sciences that already exists in Cleveland, we have been a center of excellence‚ in this area already, in everything but name,” said Juengst

The national initiative is being led by NHGRI, with significant contributions from the U.S. Department of Energy (DOE) and the National Institute of Child Health and Human Development (NICHD). The other universities receiving funding are Duke University, Durham, N.C.; Stanford University, Palo Alto, Calif.; and the University of Washington, Seattle.

“The NHGRI‚s pioneering program supporting research in the ethical, legal and social implications of genomic knowledge provides the basis for this exciting new initiative,” said NHGRI Director Francis S. Collins, M.D., Ph.D. “We will now build upon this foundation by establishing interdisciplinary research centers that can take an even more dynamic and broad-based approach to identifying and addressing some of the most pressing issues facing individuals, families and communities in the genome era.”

Each of the new centers will assemble a team of experts in several disciplines, such as bioethics, law, behavioral and social sciences, clinical research, theology, public policy, and genetic and genomic research. The interdisciplinary nature of these teams will allow the centers to develop innovative research approaches focused on specific sets of issues that relate to the numerous applications of genomic research, including the scientific goals and challenges identified by NHGRI in “A Vision for the Future of Genomics Research,” which was published in April 2003 in the journal Nature. The centers‚ output will be critical in formulating and implementing effective and equitable health and social policies related to genomic research. In addition, the centers will create new environments to support the growth of the next generation of researchers on the ethical, legal and social implications of genomic research. Special efforts will be made to recruit potential researchers from under-represented groups.

The other centers will focus on other aspects of the implications of genetics research.

The Duke Center for the Study of Public GenomicsDirected by Robert Cook-Deegan, M.D., $4.8 million

This center will assemble a team to gather and analyze information about the role of publication, data and materials sharing, patenting, database protection and other practices that may affect the flow of information in genomics research. Research pertaining to these topics will make a much-needed contribution to the understanding of how information flow influences development, commercialization and use of genomic products and services that may benefit human health.

Stanford University‚s Center for Integrating Ethics and Genetic Research Directed by Mildred Cho, Ph.D., $3.8 million

This center will focus on the ethical, legal and social consequences of uncovering the genomic contributions that may contribute to behavioral and neurological conditions. Research that examines attributes and traits that are possibly found more frequently in certain populations has the potential to stigmatize both individuals and groups. The Stanford center will work to identify and understand the issues related to this genetic research, provide consultation and guidance to genetic researchers on these issues, and develop training and education materials that can be integrated into the design and implementation of neurological and behavioral genetic studies.

University of Washington‚s Center for Genomic Health Care and the Medically UnderservedDirected by Wylie Burke, M.D., Ph.D., $4.7 million

This center will conduct research on the ethical, legal, and social factors that influence the translation of genetic information to improved human health. It will be dedicated to addressing two overarching themes resulting from the clinical integration of genomics: the need to define criteria for clinical integration that lead to clinically and socially appropriate applications of genomic health care and the need for a translational pathway that incorporates the goal of reducing health and health care disparities among the medically underserved. A major outcome will be the development of methods to inform all segments of society about technological advances, and to improve the mechanisms for obtaining input from diverse populations to help to identify and assess policy options for addressing these challenges.

In addition to funding these four centers of excellence, the NHGRI also announced the award of three exploratory grants that provide two to three years of support to investigators for planning and developing potential new centers at their institutions.

NHGRI’s Ethical, Legal and Social Implications (ELSI) Research Program was established in 1990 as an integral part of the Human Genome Project to foster basic and applied research and to support education and outreach activities. The ELSI program is the largest sponsor in the world of research on the ethical, legal and social aspects of biomedicine.

NHGRI is one of the 27 institutes and centers at NIH, an agency of the Department of Health and Human Services. For more information about NHGRI’s ELSI Research Program, see www.genome.gov/10001618. Additional information about NHGRI can be found at its Web site, www.genome.gov.

About Case Western Reserve University

Case is among the nation's leading research institutions. Founded in 1826
and shaped by the unique merger of the Case Institute of Technology and Western
Reserve University, Case is distinguished by its strengths in education, research,
service, and experiential learning. Located in Cleveland, Case offers nationally
recognized programs in the Arts and Sciences, Dental Medicine, Engineering,
Law, Management, Medicine, Nursing, and Social Work. http://www.case.edu.